ConsultaTM CRT-D Clinical Evaluation Study

Heart Failure Clinical Trial

Official title:

Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526162
• Other study ID #: 112
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: March 2019
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).

Description:

The Consulta CRT-D is an investigational bi-ventricular device that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac resynchronization therapy.

The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 18 centers.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Consulta device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have an indication for a defibrillator.

• Patients who are optimally treated with medication.

• Patients who are New York Heart Association (NYHA) Class III or IV

Exclusion Criteria:

• Patients with a life expectancy less than the duration of the study.

• Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.

• Patients with mechanical tricuspid heart valves.

Related Conditions & MeSH terms

• Heart Failure
• Tachyarrhythmias
• Tachycardia
• Ventricular Dysfunction

Intervention

Device:
• Bi-ventricular Implantable Cardioverter Defibrillator
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator

Locations

Country	Name	City	State
Germany	Hospital	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.	Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.	1 month
Secondary	Adverse Events	Number of Adverse Events reported in the implanted subjects.	1 month
Secondary	System Performance Assessed by Holter Records	The first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.	1 month follow-up
Secondary	System Performance Assessed by Save to Disk Files	94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.	1 month follow-up
Secondary	System Performance Assessed by Technical Observations	Reported technical observations will be reviewed to determine if there are any device performance issues.	1 month follow-up